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Completed

NCT Number: NCT05518084

Safety of Cell-free Adipose Tissue Product in Healthy Volunteers

The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of cell-free adipose tissue product. The safety of the tissue product is to be studied in 40 healthy volunteers. Cell-free tissue product is injected into superficial part of the subcutis with one injection to standardized area. The volume of the injection is 4,5 ml. As the control method, the same size area is injected with plain Ringer-Acetat solution. The adverse events and serious adverse events are monitored in doctor visits, phone calls and e-diary.

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Key information

Conditions

Safety Issues

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Terveystalo, Ruoholahti

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (age 18 years or more)
  • Healthy skin in the studied area (dorsal forearm, proximal third)
  • Able and willing to give informed consent
  • Reasonably accessible to the study clinic and compliant to follow-up visits

Exclusion criteria

  • known allergy to any of the preparations used in the study (Liponovo tissue product and Ringer-Acetat) or earlier/known anaphylaxis reaction for any allergen
  • hematologic or other bleeding disorder
  • use of antitrombotic/ anticoagulation medicine
  • autoimmune disease
  • immunosupressive disease or medication
  • cancer or neoplastic disease
  • connective tissue disease
  • diabetes type 1 or 2 or other metabolic diseases
  • smoking
  • pregnancy or nursing
  • sunbathing during last 7 days
  • a skin disease that is or has been symptomatic in the studied area
  • test subjects with previous fat or hyaluronic acid filling under the same area
  • those who withhold consent
  • Use of following medications:
  • Histamine receptor-blockers <7 days before study initiation
  • Topical corticosteroids in test area <7 days before study initiation
  • Topical calsineurin inhibitors <7days before study initiation
  • Longterm (>10days before study initiation) systemic prednisolon >10mg/d
  • Omalitsumabi < 4weeks before study initiation
  • Doksepin < 7 days before study initiation

Treatment and study plan

Liponovo tissue product

Other

Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. The single injection and a 23G/30mm needle are used. The amount of the injected investiogational products is 4,5 ml for both dorsal forearms (together 4,5ml x2 = 9ml / test subject). The product is always injected in the proximal third of the forearm, into a standardized a quarter circle with a radius of 30mm. Both injections are performed with covered syringe to ensure the double-blinding. After the injection, test subjects get a cold on the injection sites to reduce the bruising.

Primary outcomes

  1. Acute local reactions 20 minutes after injection

    Time frame: Day 0

    Examination and structured interview 20 minutes after injection by the investigator

  2. Acute and mid-term adverse events, incl severe adverse events

    Time frame: Day 0-7, Day 30, and Day 60

    E-dairy filled out by the participants

  3. Acute and mid-term adverse events, incl severe adverse events

    Time frame: Day 90

    Evaluation and structured interviews by the investigator

  4. Acute and mid-term adverse events, incl severe adverse events

    Time frame: Day 7 and Day 9

    Structured telephone interview by study nurse

  5. Delayed allergic reactions

    Time frame: Day 0-7, Day 30, and Day 60

    Participant's e-dairy

  6. Delayed allergic reactions

    Time frame: Day 2, and Day 7

    Telephone interviews by the study nurse

Sponsors and collaborators

Lead sponsor

Linio Biotech Oy

Industry

Collaborators

  • Clinius Ltd

Registry information

Official study title

Evaluating the Safety and Tolerability of the Liponovo Tissue Product in Healthy Volunteers

Acronym: SAFETY

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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